0363_Supporting Statement_2021

United States Food and Drug Administration
Veterinary Feed Directive
OMB Control No. 0910-0363
SUPPORTING STATEMENT
Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, we) regulations.
Section 504 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 354)
establishes a regulatory category for certain new animal drugs called veterinary feed directive
(VFD) drugs. Our VFD regulation is set forth at 21 CFR 558.6. VFD drugs are new animal
drugs intended for use in or on animal feed which are limited to use under the professional
supervision of a licensed veterinarian in the course of the veterinarian’s professional practice
(21 CFR 558.3(b)(6)). An animal feed containing a VFD drug or a combination VFD drug
may be fed to animals only by or upon a lawful VFD issued by a licensed veterinarian (21
CFR 558.6(a)(1)). Veterinarians issue three copies of the VFD: one for their own records, one
for their client (food animal producer), and one to the client’s VFD feed distributor (21 CFR
558.6(a)(4) and 558.6(b)(8) and (9)). The VFD includes information about the number and
species of animals to receive feed containing one or more of the VFD drugs (21 CFR
558.6(b)(3)), along with other information required under 21 CFR 558.6. All distributors of
medicated feed containing VFD drugs must notify us of their intent to distribute such feed and
must maintain records of the receipt and distribution of all medicated feeds containing VFD
drugs.
We therefore request OMB approval of the information collection provisions found in 21 CFR
558.6: Veterinary Feed Directive and discussed in this supporting statement.
2. Purpose and Use of the Information Collection
The VFD regulation ensures the protection of public health while enabling animal producers to
obtain and use needed drugs as efficiently and cost-effectively as possible. The VFD
regulation is tailored to the unique circumstances relating to the distribution and use of animal
feeds containing a VFD drug. We use the information collected to assess compliance with the
VFD regulation. The required recordkeeping and third-party disclosures provide assurance
that the medicated feeds will be safe and effective for their labeled conditions of use and that
edible products from treated animals will be free of unsafe drug residues.
3. Use of Improved Information Technology and Burden Reduction
The industry is increasingly turning to the use of automated production facilities. The use of
information technology is acceptable for the purposes of recordkeeping for FDA inspections.
Currently about 30% of submissions are electronic, however, we expect this number to
increase.

1

4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
The proposed collection of information carries the same burden, per VFD, for small or large
firms. There is no exemption from the requirements of the regulation for small businesses.
The agency estimates that 80% of respondents are small businesses. FDA aids small
businesses in complying with its requirements through the Agency’s Regional Small Business
Representatives and through the scientific and administrative staffs within the Agency.
Resources for small business assistance can be found on our website at
https://www.fda.gov/animal-veterinary/resources-you/cvm-small-business-assistance.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs occasionally. Most reporting and recordkeeping requirements are onetime events.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
FDA published a 60-day notice for public comment in the Federal Register of December 23,
2020 (85 FR 83968). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
There are no incentives, payments or gifts associated with this information collection.
10. Assurance of Confidentiality Provided to Respondents
In preparing this Supporting Statement, we consulted our Privacy Office to ensure appropriate
identification and handling of information collected.
This ICR collects personally identifiable information (PII). PII is collected in the context of
the subject individuals’ professional capacity and the FDA-related work they perform for their
employer (e.g., point of contact at a regulated entity). The PII submitted is name and business
address. Through appropriate instruction, FDA limited submission fields and minimized the
PII collected to protect the privacy of the individuals.
Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), the public has broad access to
government documents. However, FOIA provides certain exemptions from mandatory public
disclosure of government records (5 U.S.C. 552(b)(1-9)). FDA will make the fullest possible
disclosure of records to the public, consistent with the rights of individuals to privacy, the
property rights of persons in trade and confidential commercial or financial information.

2

11. Justification for Sensitive Questions
The collection of information does not involve sensitive questions.
12. Estimates of Annualized Burden Hours and Cost
12a. Annualized Hour Burden Estimate
A. Reporting Requirements
Description of Respondents: VFD Feed Distributors, VFD Drug Sponsors.
A distributor of animal feed containing a VFD drug must notify us prior to the first time it
distributes the VFD feed (21 CFR 558.6(c)(5)). This notification is required one time per
distributor and must include the information set forth in 21 CFR 558.6(c)(5). In addition, a
distributor must notify us within 30 days of any change in ownership, business name, or
business address (21 CFR 558.6(c)(6)). Additional reporting burdens for current VFD
drug sponsors are approved under OMB control numbers 0910–0032 (New Animal Drug
Applications) and 0910–0669 (Abbreviated New Animal Drug Applications).
Table 1.--Estimated Annual Reporting Burden 1
21 CFR Section/Activity
No. of
No. of
Total
Average
Total
Respondents Responses
Annual
Burden
Hours
per
Responses
per
Respondent
Response
558.6(c)(5) requires a
188
1
188
0.117
22
distributor to notify FDA
(7
prior to the first time it
minutes)
distributes a VFD feed
558.6(c)(6) requires a
192
1
192
0.117
22
distributor to notify FDA
(7
within 30 days of any
minutes)
change in ownership,
business name, or business
address
Total
44
1 There are no capital costs or operating and maintenance costs associated with this collection of
information.
B. Recordkeeping Requirements
Description of Respondents: VFD Feed Distributors, Food Animal Veterinarians, and
Clients (Food Animal Producers).
As stated previously, veterinarians issue three copies of the VFD: One for their own
records, one for their client, and one to the client’s VFD feed distributor. All involved
parties (the veterinarian, the distributor, and the client) must retain a copy of the VFD for 2
years (21 CFR 558.6(a)(4)). In addition, VFD feed distributors must also keep receipt and
distribution records of VFD feeds they manufacture and make them available for
inspection by us for 2 years (21 CFR 558.6(c)(3)). If a distributor manufactures the VFD
feed, the distributor must also keep VFD manufacturing records for 1 year in accordance
with part 225 and such records must be made available for inspection and copying by FDA
upon request (§ 558.6(c)(4)). These record requirements are currently approved under
3

OMB control number 0910–0152, Current Good Manufacturing Practice Regulations for
Medicated Feed. Distributors may distribute VFD to another distributor only if the
originating distributor first obtains a written acknowledgement letter. Such letters, like
VFDs, are also subject to a 2-year record retention requirement. (21 CFR 558.6(c)(8).)

Table 2.--Estimated Annual Recordkeeping Burden1
21 CFR
No. of
No. of
Total Annual
Average
Total Hours
Section/Activity Recordkeepers Records per
Records
Burden per
Recordkeeper
Recordkeeping
558.6(a)(4);
13,050
114.9
1,500,000
0.0167
25,050
required
(1 minute)
recordkeeping
by veterinarians
and producers
558.6(a)(4),
9,635
545.1
5,252,039
0.0167
87,709
(c)(3), (4), and
(1 minute)
(8); required
recordkeeping
by distributors
Total
112,759
1 There are no capital costs or operating and maintenance costs associated with this collection
of information
C. Third-Party Disclosure Requirements
Description of Respondents: VFD Drug Sponsors, Food Animal Veterinarians, VFD Feed
Distributors, and Clients (Food Animal Producers).
Our regulation requires that veterinarians include the information specified at 21 CFR
558.6(b)(3) through (b)(5) on the VFD. Additional requirements relating to the VFD are
specified at 21 CFR 558.6(b)(7) through (b)(9). A distributor may only distribute a VFD
feed to another distributor for further distribution if the originating distributor (consignor)
first obtains a written acknowledgement letter from the receiving distributor (consignee)
before the feed is shipped (21 CFR 558.6(c)(8)).
Table 3.--Estimated Annual Third-Party Disclosure Burden 1
21 CFR Section/Activity
No. of
No. of
Total
Average
Total
Respondents Disclosures
Annual
Burden per Hours
per
Disclosures Disclosure
Respondent
558.6(b)(3)-(5) and (b)(7)-(9);
3,050
246
750,300
0.117 87,785
required disclosures when a
(7 minutes)
veterinarian issues a VFD
558.6(c)(8); required
1,000
5
5,000
0.117
585
disclosure (acknowledgment
(7 minutes)
letter) from one distributor to
another
4

Total
88,335
There are no capital costs or operating and maintenance costs associated with this collection of
information.

1

The VFD regulation also contains several labeling provisions that are exempt from OMB
review and approval under the PRA because they are a “public disclosure of information
originally supplied by the Federal government to the recipient for the purpose of disclosure
to the public” (5 CFR 1320.3(c)(2)) and therefore do not constitute a “collection of
information” under the PRA (44 U.S.C. 3501, et seq.). All labeling and advertising for
VFD drugs, combination VFD drugs, and feeds containing VFD drugs or combination
VFD drugs must prominently and conspicuously display the following cautionary
statement: “Caution: Federal law restricts medicated feed containing this veterinary feed
directive (VFD) drug to use by or on the order of a licensed veterinarian” (21 CFR
558.6(a)(6)). In addition, the veterinarian must ensure that the following statement is
included on the VFD (21 CFR 558.6(b)(3)(xiii)), “Use of feed containing this veterinary
feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel
use) is not permitted.”
The veterinarian may restrict VFD authorization to only include the VFD drug(s) cited on
the VFD or such authorization may be expanded to allow the use of the cited VFD drug(s)
along with one or more over-the-counter animal drugs in an approved, conditionally
approved, or indexed combination VFD drug (21 CFR 558.6(b)(6)). The veterinarian must
affirm his or her intent regarding combination VFD drugs by including one of the
following statements on the VFD:
1. “This VFD only authorizes the use of the VFD drug(s) cited in this order and is
not intended to authorize the use of such drug(s) in combination with any other
animal drugs” (21 CFR 558.6(b)(6)(i)).
2. “This VFD authorizes the use of the VFD drug(s) cited in this order in the
following FDA-approved, conditionally approved, or indexed combination(s) in
medicated feed that contains the VFD drug(s) as a component.” [List specific
approved, conditionally approved, or indexed combination medicated feeds
following this statement.] (21 CFR 558.6(b)(6)(ii)).
3. “This VFD authorizes the use of the VFD drug(s) cited in this order in any FDAapproved, conditionally approved, or indexed combination(s) in medicated feed
that contains the VFD drug(s) as a component.” (21 CFR 558.6(b)(6)(iii)).
These labeling statements are not subject to review by OMB because, as stated previously,
they are a “public disclosure of information originally supplied by the Federal government
to the recipient for the purpose of disclosure to the public” (5 CFR 1320.3(c)(2)) and
therefore do not constitute a “collection of information” under the PRA (44 U.S.C. 3501, et
seq.).

12b. Annualized Cost Burden Estimate
Table 4.--Annualized Cost Burden Estimate
Type of Respondent

Total Burden Hours
5

Hourly Wage Rate

Total
Respondent

Cost
VFD Feed
Distributors
(Reporting)
VFD Feed
Distributors
(Recordkeeping,
Third-party
Disclosure)
Veterinarians
(Recordkeeping,
Third-Party
Disclosure)
Clients
(Recordkeeping)
TOTAL

44

$77.00

$3,388

88,294

$72.00

$6,357,168

87,785

$66.00

$5,793,810

25,050

$33.00

$826,650

201,138

$12,981,016

For Feed Distributors, FDA estimates notifications to FDA to be completed by personnel at the
general and operations manager level. In 2019, the Bureau of Labor Statistics’ Occupation
Employment and Wage data reported the mean wage of about (including a 30% increase for
benefits) $77.00 hour. FDA estimates other information collection tasks (recordkeeping and
issuance of acknowledgement letters) to be completed by personnel at the industrial production
manager level, at a total compensation rate (including benefits) of about $72.00 per hour.
FDA estimates that there are about 3,050 veterinarians that exclusively treat food-producing
animals. We use the 2019 Bureau of Labor Statistics’ Occupation Employment and Wage data
that reports the mean wage of about $50.00 and adjust it to include the additional 30% for
benefits. The result is an estimated compensation rate of about $65.00 per hour.
For clients (food animal producers), FDA uses the 2019 Bureau of Labor Statistics’
Occupation Employment and Wage data that reports the median wage of a first-line supervisor
of farming, fishery, and forestry workers (including benefits) of about $33.00 per hour.
13. Estimates of Other Total Annual Costs to Respondents/Recordkeepers or Capital Costs
There are no capital, start-up, operating or maintenance costs associated with this information
collection.
14. Annualized Cost to the Federal Government
We estimate the annualized cost to the Federal Government for the review and evaluation of
notifications submitted by VFD drug sponsors to be $11,853.00. We estimate that we expend
approximately 300 hours annually in the review of these submissions. We estimate the
average hourly wage for personnel to review and evaluate a submission to be at the GS-11-5
level in the locality pay area of Washington-Baltimore in 2021, approximately $39.51/hour.
Thus, the estimated annualized cost to the Federal government is $11,853.00 (300 hours x
$39.51/hour = $11,853.00).

6

15. Explanation for Program Changes or Adjustments
This information collection reflects adjustments since last OMB approval. We attribute the
increase in reporting, recordkeeping, and cost burden to the significant increase in the number
of VFD distributors that have transitioned new animal drugs from over-the-counter to VFD
marketing status. This is a result of VFD regulations that were implemented by a rule that
published in 2015. Not all distributors transitioned right away. As a result, we believe that the
numbers are now a better representation of the distributors.
We have since decreased the number of new distributors required to submit first-time
notifications. We have also since increased the number of respondents submitting updated
notifications for business changes due to the higher number of VFD distributors subject to
VFD reporting requirements since the previous collection.
Because we attribute the increased number to the information collection, we have increased
our estimate of the associated burden accordingly. The information collection, therefore,
reflects a cumulative increase in burden by 4,502,029 annual responses and 69,148 burden
hours.
16. Plans for Tabulation and Publication and Project Time Schedule
This information collected will not be published or tabulated.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
We are not seeking approval to exempt display of the OMB approval date on any documents
that are associated with this information collection.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

7